Mindfulness And Placebo for Pain (MAPP) Study

NCT ID: NCT06720909

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2027-03-31

Brief Summary

This study proposes a three-arm randomized-controlled trial (RCT) that evaluates the feasibility and acceptability of combining a mindfulness-based therapy (MBT) and open-label placebo (OLP) treatment for individuals with chronic pain. Individuals with chronic pain will be recruited to participate in an 8-week trial, with a subsequent 3-month post-treatment follow-up.

Participants will be randomly assigned to one of the following three conditions:

1. Mindfulness-Based Stress Reduction (MBSR)

2. OLP treatment

3. combination of MBSR and OLP treatment

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBSR-Only

This experimental arm receives the 8-week MBSR program only.

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR)

Intervention Type: BEHAVIORAL

The standard 8-week MBSR program will be led by certified MBSR instructors from the UCSD Center for Mindfulness. The program content will consist of a variety of mindfulness and meditative techniques, such as sitting meditation, body scans, and mindful yoga. Participants will engage in weekly sessions via Zoom, participation in group discussions, and honing their other mindfulness skills. Throughout the program, participants will be instructed to commit to a daily mindfulness meditation practice lasting approximately 45 minutes, at least 6 days a week.

OLP-Only

This experimental arm receives the OLP treatment only.

Group Type: EXPERIMENTAL

Open-Label Placebo (OLP)

Intervention Type: OTHER

The placebo pills will be size #1 capsules filled with (1) microcrystalline cellulose, a common inert excipient for pharmaceuticals, and (2) 25 mg riboflavin tracer. Participants will be informed that the placebo pills are inactive substances, like sugar pills, and contain no active medication. Then, they will watch a brief introduction video which will cover four main discussion points: (1) the placebo effect can be powerful and can have beneficial effects for diverse symptoms, (2) the body can respond to taking placebo pills automatically despite the knowledge that it is placebo (e.g., Pavlov's dogs), (3) a positive attitude or expectation can be beneficial but is not necessary, and (4) taking the pills faithfully throughout the intervention period is critical.

MBSR+OLP

This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment.

Group Type: EXPERIMENTAL

MBSR+OLP

Intervention Type: OTHER

This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.

Interventions

Mindfulness-Based Stress Reduction (MBSR)

The standard 8-week MBSR program will be led by certified MBSR instructors from the UCSD Center for Mindfulness. The program content will consist of a variety of mindfulness and meditative techniques, such as sitting meditation, body scans, and mindful yoga. Participants will engage in weekly sessions via Zoom, participation in group discussions, and honing their other mindfulness skills. Throughout the program, participants will be instructed to commit to a daily mindfulness meditation practice lasting approximately 45 minutes, at least 6 days a week.

Intervention Type: BEHAVIORAL

Open-Label Placebo (OLP)

The placebo pills will be size #1 capsules filled with (1) microcrystalline cellulose, a common inert excipient for pharmaceuticals, and (2) 25 mg riboflavin tracer. Participants will be informed that the placebo pills are inactive substances, like sugar pills, and contain no active medication. Then, they will watch a brief introduction video which will cover four main discussion points: (1) the placebo effect can be powerful and can have beneficial effects for diverse symptoms, (2) the body can respond to taking placebo pills automatically despite the knowledge that it is placebo (e.g., Pavlov's dogs), (3) a positive attitude or expectation can be beneficial but is not necessary, and (4) taking the pills faithfully throughout the intervention period is critical.

Intervention Type: OTHER

MBSR+OLP

This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. ≥18 years old;

2. ability to speak, write, and read in English;

3. physical pain present on at least half the days in the past 3 months; and

4. average past week pain severity rating ≥3 on a 0-10 Numerical Rating Scale.

Exclusion Criteria

1. acute pain due to recent injury or surgery;

2. self-reporting of chronic malignant pain (e.g., cancer, HIV);

3. self-reporting of Raynaud's disease (those who can be contraindicated for cold pressor testing);

4. severe psychopathology (e.g., a psychotic disorder) or significant cognitive deficits judged to interfere with study procedures;

5. currently pregnant or breastfeeding;

6. inability to discontinue use of vitamin B2 supplements or a multivitamin containing vitamin B2 throughout the study period (these interfere with riboflavin tracer-OLP treatment adherence-monitoring);

7. inability to commit to study period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Chung Jung Mun

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chung Jung Mun, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University Downtown Phoenix Campus

Phoenix, Arizona, United States

Site Status: RECRUITING

Arizona State University

Phoenix, Arizona, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Chung Jung Mun, PhD

Role: CONTACT

chungjung.mun@asu.edu

602-496-0809

Ryan Eckert, MS

Role: CONTACT

ryan.eckert@asu.edu

602-496-0665

Facility Contacts

Chung Jung Mun

Role: primary

cjmun@asu.edu

(602) 496-2644

Chung Jung Mun, PhD

Role: primary

chungjung.mun@asu.edu

602-496-0809

References

Mun CJ, Contreras E, Xiao Y, Eckert R, Harting A, Damera S, Perez I, Pandey HK, Mardian AS, LoVecchio F, Colloca L, Dunn KE, Todd M, Fillingim RB, Davis MC. Combining mindfulness intervention and open-label placebo treatment for chronic pain: a protocol for a feasibility study. Pilot Feasibility Stud. 2025 Aug 20;11(1):111. doi: 10.1186/s40814-025-01692-8.

Reference Type: DERIVED

PMID: 40836262 (View on PubMed)

Other Identifiers

1R34AT012677

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00020051

Identifier Type: -

Identifier Source: org_study_id